The following data is part of a premarket notification filed by Pillar Surgical, Inc. with the FDA for Silmax Contour Carving Block Implant.
| Device ID | K002629 |
| 510k Number | K002629 |
| Device Name: | SILMAX CONTOUR CARVING BLOCK IMPLANT |
| Classification | Polymer, Ent Synthetic, Porous Polyethylene |
| Applicant | PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
| Contact | Rob Fritzenkotter |
| Correspondent | Rob Fritzenkotter PILLAR SURGICAL, INC. P.O. BOX 8141 La Jolla, CA 92038 |
| Product Code | JOF |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-23 |
| Decision Date | 2000-11-20 |